An opening for a Senior Regulatory Affairs Specialist has arisen within a renowned Limerick based medical device multinational. The successful candidate will assist in the running of the regulatory affairs by providing input into the required functional areas.
Assists in the running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required.
Understands the progress of the RA team on assigned tasks.
Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed.
Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
Develops global regulatory strategies in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
Ensures the biocompatibility and clinical requirements of the product are adequately addressed.
Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
Qualifications and Experience
Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required.
Knowledge of requirements in other jurisdictions where required.
Knowledge of medical device quality standards/practises or similar regulated industry.
Good communication and inter-personal skills.
Proven problem-solving skills.
Approved External Auditor.